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Laryngoscope. 2016 Nov;126(11):2618-2623. doi: 10.1002/lary.25909. Epub 2016 Mar 24.

Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six-month results.

Author information

1
Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A.. mfriedman@chicagoent.com.
2
ENT and Allergy Associates, Orange Regional Medical Center, Middletown, New York, U.S.A.
3
Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A.
4
Head and Neck Department, St. Joseph Hospital, Bremen, Germany.
5
Department of Cardiology, Center of Sleep Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.
6
Saint Luc University Clinics, Department of Oto-Rhino-Laryngology, Institute of Neurosciences, University of Louvain, Brussels, Belgium.
7
Colorado Head and Neck Specialists, Denver, Colorado, U.S.A.
8
Mannheim University ENT Clinic, Mannheim, Germany.

Abstract

OBJECTIVES/HYPOTHESIS:

This feasibility study was designed to show the preliminary safety and efficacy of targeted hypoglossal neurostimulation (THN), and to identify baseline predictors of successful therapy.

STUDY DESIGN:

Open-label, prospective, multicenter, single-arm cohort study, conducted at seven centers in the U.S.A. and Europe.

METHODS:

Forty-six participants with moderate to severe obstructive sleep apnea (OSA), failing or intolerant of continuous positive airway pressure, were implanted. Primary (Apnea-Hypopnea Index [AHI], Oxygen Desaturation Index [ODI]) and secondary (Arousal Index, Epworth Sleepiness Scale Index, Sleep Apnea Quality of Life Index) outcomes were measured at baseline and compared at 6 months. Data were analyzed to identify participant characteristics that would predict success with therapy.

RESULTS:

Sixty-seven adverse events (AEs) were observed among 36 participants; most of the AEs were related to the implant procedure and resolved without sequelae; one device replacement was necessary. Forty-three participants showed significant (P < .01) decreases in both AHI and ODI at 6 months; 35% (15 of 43) met criteria for AHI responders and 40% (17 of 43) for ODI responders. Significant improvement was observed in all the secondary endpoints. Predictors-of-success selection criteria were identified as baseline AHI < 65/hr, baseline apnea index ≤ 30, baseline body mass index < 35, and <15 events/hr of SpO2 decrease > 10%. Seven participants met these criteria; 86% (6 of 7) were AHI responders and 86% (6 of 7) were ODI responders, indicating that THN therapy can be efficacious in a carefully selected population of OSA patients.

CONCLUSIONS:

This feasibility study suggests that THN therapy is likely to be safe and effective in selected patients.

LEVEL OF EVIDENCE:

2b Laryngoscope, 126:2618-2623, 2016.

KEYWORDS:

Hypoglossal nerve stimulation; hypoglossal nerve; neurostimulation; obstructive sleep apnea; surgical treatment of obstructive sleep apnea

PMID:
27010361
DOI:
10.1002/lary.25909
[Indexed for MEDLINE]

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